Time to progression at which a 5-point or greater Model for End stage Liver Disease (MELD) score is recorded relative to baseline [ Time Frame: From Baseline up to Study Day 91 ] [ Designated as safety issue: No ]

This is based on death or the first observed increase of at least 5 points from Baseline MELD score (whichever occurs earlier) at least 24 hours after the ELAD® Treatment Period is ended and up to Study Day 91 (90 days following Baseline).

Secondary Outcome Measures:

Time to progression at which a 5-point or greater MELD score is recorded relative to baseline [ Time Frame: From Baseline up to Study Day 91 ] [ Designated as safety issue: No ]

A secondary Overall Survival analysis will use the same methodology as the primary time to progression efficacy analysis, except that an event will be defined as death. Secondary efficacy analyses will evaluate the proportion of progression free survivors (MELD score increased less than 5 points relative to the Baseline MELD score).

Use of ELAD for up to 6 days to stabilize liver function plus standard of care treatment plus standard of care treatment. Standard of care for acute on chronic hepatitis patients including medications and treatments typically given to patients admitted with acute hepatitis (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

Biological: ELAD plus standard of care treatment

Use of ELAD plus standard of care

Other Name: Extra corporeal liver assist system

Other: Standard of care

Standard of care in the treatment of AOCH will be administered

Standard of care

Standard of care for acute on chronic hepatitis patients including medications and treatments typically given to patients admitted with acute hepatitis (Pentoxifylline, corticosteroids, abdominal paracentesis, nutritional therapy, etc., if indicated)

Other: Standard of care

Standard of care in the treatment of AOCH will be administered

Eligibility

Ages Eligible for Study:

18 Years to 67 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age >/= 18</= 67 years; AND

Acute decompensation of chronic liver disease over the preceding 30 days; AND

MELD score between 18 and 35, inclusive; AND

Subject or designated representative must provide Informed Consent

Exclusion Criteria:

Platelets <50,000mm at baseline; OR

Evidence of chronic renal failure as defined by a serum creatinine >/= 2.5mg/dL as measured during the 1-6 month period prior to study entry. (Subject is not excluded with a creatinine >2.5 mg/dL if deemed to be type-1 hepato-renal syndrome); OR

Contraindication to renal replacement therapy (hemodialysis or hemofiltration); OR

International Normalization Ratio (INR) > 3.5; OR

Septic shock as defined by a positive blood culture and two or more of the following:

Subjects with a recent history of gastrointestinal hemorrhage who have been successfully treated and remain hemodynamically stable for a period of 48 hours will then be eligible for the study if the investigator determines the subject to be at low risk for rebleeding; OR

Known history of hepatocellular carcinoma beyond the Milan criteria and/or portal vein thrombosis; OR

Evidence of spontaneous bacterial peritonitis with uncontrolled infection; OR

Evidence of brain death as determined by blood flow studies positive for herniation AND/OR absence of pupillary reflex; OR

Systolic blood pressure <85 mmHg OR MAP <50mmHg at baseline; OR

Requirement for escalating doses of vasopressor support OR of an alpha-adrenergic agent for one hour or longer AND evidence of hemodynamic instability; OR

Subject at maximum vasopressor dose at Screen; OR

Clinical or radiographic evidence of a new stroke or intracerebral bleeding; OR

Seizures uncontrolled by medication; OR

Acute myocardial infarction based on clinical and/or electrocardiographic evidence; OR

Lung disease defined by a PaO2<60mmHg on room air, acute respiratory distress syndrome, or a history of severe COPD or interstitial lung disease; OR

Pregnancy as determined by beta-HCG results or lactation; OR

Participation in another investigational drug, biologic, or device study within 1 month of enrollment. Subjects enrolled in an observational study will be eligible for this trial.

Previous liver transplant.

Previous participation in a clinical trial involving ELAD.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973817